Use of Acupuncture for Stimulation of Labour
Primary Purpose
Dystocia
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Acupuncture og acupressure when diagnosed with dystocia
Sponsored by
About this trial
This is an interventional treatment trial for Dystocia focused on measuring dystocia, stimulation, acupuncture, oxytocin
Eligibility Criteria
Inclusion Criteria: Normal pregnancy In labour (orificium < 8 cm), 37th week or thereafter Ruptured membranes Primary or secondary inertia - Exclusion Criteria: Pathological pregnancy Pathological labour Medical diseases Women who do not speak and undrestand danish
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
use of oxytocin
number of contractions/30 minutes
Full Information
NCT ID
NCT00279071
First Posted
January 18, 2006
Last Updated
July 1, 2008
Sponsor
Herning Hospital
Collaborators
Ringkjøbing County Research Fond, Union of Midwives Research Fond
1. Study Identification
Unique Protocol Identification Number
NCT00279071
Brief Title
Use of Acupuncture for Stimulation of Labour
Official Title
Use of Acupuncture for Stimulation of Labour
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Terminated
Why Stopped
exhausted personel after a long recruiting period
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Herning Hospital
Collaborators
Ringkjøbing County Research Fond, Union of Midwives Research Fond
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypothesis:Acupuncture can be used as stimulation of labour in case of primary og secondary inertia.
A randomized controlled trial including 150 pregnant women Acupuncture has become a natural part of the range of obstetric treatments offered in danish delivery wards, but there is only little evidence to the effect of the acupuncture.
The women are randomized into to groups.
Acupuncture, Acu.points: KI3, Ki6, SP6, BL60, LI4, BL67(acupressure)
No treatment
The women will be asked in case beginning signs of inertia, if they want to parcipitate in the trial.
Inclusion criteria:
Normal pregnancy
In labour (orificium < 8 cm), 37th week or thereafter
Ruptured membranes
Primary or secondary inertia
The women will just before randomization be vaginally explored and fetal heart monitored. The meassure of effect happens two hours after randomization.
The midwife who measures the effect, is blinded to the treatment or lack of, and also on the including exploration.
Secondary effect meassures: length of labour, use of oxytocin and number of contracions pr/min meassured twice:
1. before the randomization and again 1 hour after randomization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystocia
Keywords
dystocia, stimulation, acupuncture, oxytocin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Acupuncture og acupressure when diagnosed with dystocia
Intervention Description
Acupuncture points: sp6 li4 ki3 ki6 bl60 Acupressure points: bl67
Secondary Outcome Measure Information:
Title
use of oxytocin
Time Frame
additional need for oxytocin infusion in 1. stage and 2. stage
Title
number of contractions/30 minutes
Time Frame
number og contractions in 1st. stage and 2nd. stage
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Normal pregnancy
In labour (orificium < 8 cm), 37th week or thereafter
Ruptured membranes
Primary or secondary inertia -
Exclusion Criteria:
Pathological pregnancy
Pathological labour
Medical diseases
Women who do not speak and undrestand danish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjeld Rasmussen, obst. dr.med
Organizational Affiliation
Obstetric ward Herning and Holstebro hospitals
Official's Role
Study Chair
12. IPD Sharing Statement
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Use of Acupuncture for Stimulation of Labour
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